21 CFR § 884.2730 - Home uterine activity monitor.

---
identifier: "/us/cfr/t21/s884.2730"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.2730 - Home uterine activity monitor."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.2730"
section_name: "Home uterine activity monitor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 884.2730 Home uterine activity monitor.

(a) *Identification.* A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

(b) *Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]